Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patient admitted to the hospital with a primary diagnosis of ADHF
• Patient has signs of volume overload as evidence by a score of ≥ 4 on the EVEREST score
• Patient with Left Ventricular Ejection Fraction LVEF \>15%
• Patient has compromised response to diuretics
• NT-proBNP \>450 pg/mL if aged \<55 years, \>900 pg/mL if aged between 55 and 75 years and \>1800 pg/mL if aged \>75 years
Locations
Other Locations
Israel
Rambam Medical Center
RECRUITING
Haifa
Shaare Zedek Medical Center
RECRUITING
Jerusalem
The Baruch Padeh Medical Center, Poriya
RECRUITING
Poria Illit
Kaplan Medical Center
RECRUITING
Rehovot
Contact Information
Primary
Sagy Karavany
sagy@nephronyx.com
972-8-9999734
Time Frame
Start Date: 2022-12-19
Estimated Completion Date: 2026-07
Participants
Target number of participants: 10
Treatments
Experimental: ADHF patients
ADHF patients with compromised response to diuretics treated with Nephronyx system
Related Therapeutic Areas
Sponsors
Leads: Nephronyx LTD